Senior Biotech Manufacturing Associate (24/7 Ops)

FUJIFILM Holdings America Corporation; Holly Springs (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC seeks a Senior Manufacturing Associate to lead day‑to‑day operations on a 24/7 manufacturing floor and drive readiness for a new facility.

You will coach teammates, ensure cGMP compliance, supervise processing steps, and collaborate across functions to scale up drug substance production. This role offers hands‑on problem solving, extensive training, and an opportunity to help bring lifesaving therapies from concept to clinic.

Qualifications

• Minimum education and experience as stated: HS + 8 yrs life sciences manufacturing, or Associate +6 yrs, or BA/BS +4 yrs, or equivalent military experience.
• Proficiency in cGMP regulations and pharmaceutical standards.
• Functional area qualification with cross‑unit expertise across all operations.

Responsibilities

• Serve as a key contributor for operational readiness in bulk drug substance manufacturing.
• Support commissioning and qualification of equipment.
• Create and/or review procedures and SOPs.
• Help onboard manufacturing staff and transfer or develop manufacturing business processes.
• Support new item creation and single‑use assembly transfer or design.
• Champion a strong safety culture and follow EHS protocols.
• Lead, execute, and document manufacturing steps and support activities, ensuring SOPs and cGMP adherence.
• Monitor and control processes, perform in‑process testing as needed.
• Execute validation protocols per cGMP SOPs and provide approvals as backup.

Skills

cGMP knowledge

Team leadership

Troubleshooting

Documentation

Training & mentoring

Process monitoring

Education

High school diploma or GED

Associate degree

BA/BS in Life Sciences or Engineering

Equivalent military experience

Job description

FUJIFILM Biotechnologies in Holly Springs, NC seeks a Senior Manufacturing Associate to lead day‑to‑day operations on a 24/7 manufacturing floor and drive readiness for a new facility.

You will coach teammates, ensure cGMP compliance, supervise processing steps, and collaborate across functions to scale up drug substance production. This role offers hands‑on problem solving, extensive training, and an opportunity to help bring lifesaving therapies from concept to clinic.